NCT04853992

Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria

Phase 2a Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: JW Pharmaceutical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 2a trial to assess the efficacy and safety of LEO 152020 in adult patients with cholinergic urticaria

Detailed description

This is a phase 2a, randomised, double-blind, placebo-controlled, cross-over trial conducted in Germany at 3-6 sites. Subjects will be randomised to one of two treatment sequences (A and B). Each treatment period will last 7 days with a wash-out period of 7 days between treatments. Half of the subjects will start with treatment A followed by treatment B while the other half will start with treatment B followed by treatment A. A safety follow-up visit will be performed 3 days after last dose of the tested medication. The main assessment is an urticaria activity score. After a Pulse-controlled ergometry (PCE) provocation test subjects will be rated on their number of wheals and their itch severity, resulting in a sum score ranging from 0 to 6 points.

Conditions

• Cholinergic Urticaria

Interventions

Type	Name	Description
DRUG	LEO 152020	LEO 152020 is a small drug molecule which can block the histamine 4 receptor (H4R). LEO 152020 is a tablet for oral administration.
DRUG	LEO 152020 placebo	LEO 152020 placebo is a tablet for oral administration. LEO 152020 placebo contains the same excipients in the same concentration as the LEO 152020 tablet, except the medical ingredient, LEO 152020.

Timeline

• Start date: 2021-05-10
• Primary completion: 2022-07-08
• Completion: 2022-07-11
• First posted: 2021-04-22
• Last updated: 2024-04-22
• Results posted: 2024-03-21

Locations

6 sites across 1 country: Germany